Clinical Trial: A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase Ia, Multicenter, Open-Label, Single-Dose, Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With
Brief Summary: The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome: Safety and tolerability of the study drug [ Time Frame: Through study completion or early study discontinuation ]
Original Primary Outcome: Same as current
Current Secondary Outcome: PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration) [ Time Frame: Through study completion or early study discontinuation ]
Original Secondary Outcome: Same as current
Information By: Genentech, Inc.
Dates:
Date Received: September 8, 2009
Date Started: September 2009
Date Completion:
Last Updated: February 2, 2012
Last Verified: February 2012